Healthcare Industry News:  hysteroscopy 

Devices Surgery Regulatory

 News Release - July 27, 2007

OmniGuide Announces CE Mark Approval of Flexible CO2 Laser Fibers

CAMBRIDGE, Mass., July 27 (HSMN NewsFeed) -- OmniGuide, Inc. ( today announced TUV Rheinlad has approved OmniGuide Products for CE Mark. This will make flexible fiber delivery of a CO2 laser for minimally invasive surgery available in Europe and other countries that accept the CE Mark.

The OmniGuide system is indicated for multiple applications including:

"The incision, excision, ablation, vaporization and coagulation of body soft tissues including intra-oral tissues. It is indicated in the medical specialties of general and plastic surgery, oral/maxillofacial surgery, dentistry, dermatology, gynecology, otorhinolaryngology, gastroenterology, neurosurgery, urology, and pulmonology, and can be used in open surgical procedures as well as endoscopic minimally invasive procedures in conjunction with rigid or flexible endoscopes, such as in laryngoscopy, gastroscopy, colonoscopy, laparoscopy, thoracoscopy, hysteroscopy and bronchoscopy."

"The CE Mark approval of our flexible fiber delivery system for CO2 lasers is a significant step forward for our surgical business," said Prof. Yoel Fink, OmniGuide Founder, "This is the next step in opening new opportunities through additional markets for the surgical product portfolio based on OmniGuide's CO2 fiber technology. The approval will allow OmniGuide to fully engage the surgical market in CE countries and drive new minimally invasive treatment modalities in multiple specialties."

Surgical cases will be performed initially by the Department of Otolaryngology at the CHUV Medical Center in Lausanne, Switzerland with Prof. Monnier, Dr. Pasche, Dr. Lang and primary investigator Dr. Luc Bron.

About OmniGuide Technology

The OmniGuide OtoBeam and BeamPath systems are FDA-cleared and CE Marked devices, and have treated over 700 patients in approximately 130 U.S. medical facilities. CO2 laser energy offers unparalleled precision and a high degree of control over penetration into soft tissue. These attributes are critical in otology, laryngology, head and neck surgery, and pulmonology procedures for which there is the potential to damage delicate untargeted structures. 20,000 CO2 lasers have been deployed in operating rooms throughout the world. However, until now, CO2 lasers have limited applications to invasive surgery due to the absence of a fiber delivery system at their wavelength of operation.

The key to OmniGuide's technology is a revolutionary photonic bandgap fiber that was originally invented and developed at MIT. The company holds an exclusive license from MIT and has added an extensive portfolio of related US and international patents. The technology was first published in Nature in 2002.

For more information, please contact:

Doug Hutchison, VP Sales and Marketing,

Source: OmniGuide

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